tbuckley/cabot-search huggingface dataset:
Do Chinese/Chinese-American patients prefer indirect communication methods?
Authors: Maria Galkin, Weiran Lu, Tamara Vesel
Journal: Journal of Clinical Oncology (2023)

e24195 Background: Cancer care requires high quality, patient-centered communication. Existing studies of communication preferences of Chinese/Chinese-American pts suggested that they prefer an indirect approach to bad news. We administered the Measure of Patient Preferences (MPP) to pts at our cancer center, many of whom identify as Chinese or Chinese-American. The MPP is a survey comprised of 46 communication-related statements patients (pts) rate on the Likert scale centered on bad news delivery, published by Parker et al in 2001. Methods: The MPP was used with the original author’s permission. Pts were approached in private settings after screening through the EMR. All survey items, including demographic data, were optional. Pts self-identified as Chinese. Forms were available in English, simplified and traditional Chinese. Pts could complete the survey on paper, online, or return by mail. The first statistical analysis found means and medians of data to discover highest and lowest rated communication aspects. Results: Among 185 pts, 52% were women. 9% identified as Chinese (10% total Asian), 73% were white, 17% were black, Latino, other or did not provide data. 29% had a high school education or less, 28% had attended some college, 38% had a college education or higher (data missing for 5%). 57% of pts were older than 65. Malignancies included 18% hematologic, 16% ENT, 13% gynecologic, 10% lymphomas, 9% breast, 8% lung (the rest were comprised of GU, GI, skin, other, and pts who did not provide data). The top rated measures, including some of “directness,” are listed below. Scale was as follows: 1. Not important; 2. Optional; 3. Important; 4. Very important; 5. Essential. The lowest rated measures were “The doctor holding my hand or touching my arm while telling me the news” (2.22 all, 2.5 Chinese) and “My doctor helps me figure out how to tell my family and friends about the cancer” (2.82 all, 3.17 Chinese). Conclusions: Pts placed high value on having doctors tell them the best treatment and having their questions answered. The “directness” preferences between all versus Chinese pts were numerically very similar, challenging existing knowledge. Further analysis and studies are needed.[Table: see text]
Uncommon <i>EGFR</i> mutations conducted with osimertinib in patients with NSCLC (UNICORN): A phase 2 study.
Authors: Yusuke Okuma, Kaoru Kubota, Mototsugu Shimokawa, Kana Hashimoto, Yosuke Kawashima, Tomohiro Sakamoto, Hiroshi Wakui, Shuji Murakami, Kyoichi Okishio, Kenji Hayashihara, Yuichiro Ohe
Journal: Journal of Clinical Oncology (2023)

9045 Background: Non-small cell lung cancer (NSCLC) harboring uncommon EGFR mutation (uC- EGFRm), excluding exon 20 insertion, is a heterogenous rare fraction consisting of 10% of all EGFR mutations. Key drugs for metastatic NSCLC (mNSCLC) uC- EGFRm are limited, with only afatinib being FDA approved. Data on the efficacy of osimertinib for previously untreated metastatic patients (pts) harboring uC- EGFRm NSCLC is limited. Methods: UNICORN study for previously untreated mNSCLC pts harboring uC- EGFRm, excluding exon 20 insertion mutation, evaluating osimertinib with a dose of 80 mg QD orally is a multicenter, open-label, single-arm phase 2 study. The primary endpoint was the overall response rate (ORR) evaluated by central review according to the Response Evaluation Criteria in Solid Tumors (version 1.1), and key secondary endpoints were disease control rate (DCR), progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety. Results: Between March 2020 to May 2022, a total of 42 pts were registered. Among the eligible 40 pts, 45.0% were female; the median age was 72 years (range 39-88); 42.5% were never smokers or light smokers; 92.5% were adenocarcinomas, solitary uC- EGFRm/compound mutation ratio was 57.5%/42.5%. The most common mutations were G719X (50.0%), followed by S768I (25.0%), L861Q (20.0%), and others, including compound mutation data. The ORR was 55.0 % (90% confidence interval [CI]; 40.9-68.5), the DCR was 90.0 % (95% CI; 76.3-97.2), the mPFS was 9.4 months (95% CI; 3.7-15.2) after a median follow-up of 27.0 months, the mOS was not reached (NR) (95% CI, 19.23- NR), and the mDoR 22.7 months (95% CI; 9.43-NR). In solitary and compound mutations with uC- EGFR m NSCLC, ORR was 52.2%/58.8%, mPFS was 5.4 months/11.4 months, mOS 23.0 months/NR, and mDoR was 22.7 months/NR, respectively. Safety was similar to previous reports and Grade 3/4 AEs were reported in 8 of 36 pts (27.5%) and 12.5% of pts developed pneumonitis. All of the AEs were manageable and there were no treatment-related deaths. Conclusions: Osimertinib in mNSCLC pts harboring uC- EGFRm other than exon 20 insertions showed clinical activity with manageable toxicities. These results suggest that osimertinib can be considered as a treatment option for this specific population. Clinical trial registration: jRCTs071200002. The study was funded by AstraZeneca. Clinical trial information: jRCTs071200002 .
Real world data on off-label use of consolidation durvalumab in newly diagnosed stage II and recurrent non-small cell lung cancer patients treated with definitive chemoradiotherapy.
Authors: Corey Wise, Mark Mangurian, Shika Marur, Melissa Pozotrigo, Andrew Toler, Laura Rose Bobolts, Andrew D. Norden, Shanthi Marur
Journal: Journal of Clinical Oncology (2023)

e18857 Background: Consolidation durvalumab is approved for treatment of newly diagnosed, unresectable stage III non-small cell lung cancer (NSCLC) who have not progressed after definitive chemoradiotherapy (CRT) and the NCCN guidelines has since included stage II NSCLC who have not progressed after definitive CRT. Methods: A retrospective, observational real-world study was conducted to identify and describe the off-label use of consolidation durvalumab in NSCLC after completion of CRT between June 2018-June 2021. Data sources included claims data and electronic medical records submitted with prior authorization (PA) requests to OncoHealth, a digital health company that reviews PA requests for cancer treatment. With a data cut-off of 12/22/2022, real-world Time to Progression (rwTTP) and real-world Time to Next Treatment (rwTTNT) were evaluated. All endpoints were measured from the start of consolidation durvalumab treatment; rwTTP spanned until earliest date of clinician-reported progression and rwTTNT spanned until initiation of subsequent treatment. Results: Among 326 patients identified to have received durvalumab after definitive CRT, 45 (13.8%) received off-label treatment. The median age was 71 years (range: 53 to 88), 51% male, 53% former smokers, 29% Stage I, IIA or IIB, 71% locoregional recurrent disease; 58% squamous histology, 47% had undergone prior surgery +/- adjuvant chemo, 27% received prior radiation only and 98% received concomitant platinum-based chemotherapy prior to durvalumab. Median time to initiating durvalumab after CRT was 47 days. After a median follow up of 13.1 (range: 7.0-50.7) months, 33% (n = 15) had progression of disease. The median rwTTP was 14.0 (range: 4.2-32.9) months and median rwTTNT was 14.7 (range: 6.0-33.0) months. Conclusions: In the real world, off-label use of consolidation durvalumab was based on clinical justification and extrapolation of results from PACIFIC trial. The results of rwTTP and rwTTNT outcomes suggest patients with early stage or recurrent disease achieved clinically meaningful benefit from treatment approach used in the PACIFIC trial. With additional patients and longer follow up, real-world data could shed light on the appropriateness of expanding off-label use of durvalumab consolidation.
A first-in-human, open-label, dose escalation and expansion study of orally administered NX-019 in patients with advanced EGFR mutant cancer.
Authors: Alexander I. Spira, Dong-Wan Kim, Myung-Ju Ahn, Sang-We Kim, Min Hee Hong, Rachel Dusek, Guy M. Gammon, Keith Wilson, James Chih-Hsin Yang, Erminia Massarelli
Journal: Journal of Clinical Oncology (2023)

TPS9159 Background: CNS involvement, brain metastases and/or leptomeningeal disease, is common in patients with EGFR mutant NSCLC and occurs in 25-50% of patient’s journeys. Despite the activity and increased CNS penetration of later generation EGFR inhibitors, management of CNS disease remains a clinical challenge. NX-019 is a broad-spectrum EGFR inhibitor targeting both common and rare mutations including EGFR ex20ins, G719S, and L861Q. NX-019 exhibits selective activity towards mutant vs. wt. EGFR in preclinical studies. Substantial CNS exposure has been demonstrated in animal models, as well as potent anti-tumor activity toward intracranial xenografts with prolonged inhibition of EGFR signaling. Similar drug levels compared to plasma were measured in the brains of rats and mice. NX-019 was readily detectable in the CSF of cynomolgus monkeys, dogs and rats at concentrations similar to the estimated plasma free fraction. Methods: NT019-101 is a first-in-human, international, open-label study designed to evaluate single-agent NX-019 in patients with EGFR-mutant, locally advanced or metastatic NSCLC that has progressed following prior treatment. Patients with ECOG performance status 0–2 and EGFR mutant cancers including stable, asymptomatic brain metastases are eligible for Dose Escalation. Patients with known EGFR C797S mutations and secondary drivers, e.g., MET amplification and RET fusions, are excluded. Primary endpoints are to determine recommended phase 2 dose (RP2D), maximum tolerated dose (MTD), safety and tolerability (part 1), and to evaluate antitumor activity at the RP2D by RECIST v1.1 and RANO-BM (part 2). Secondary endpoints are to evaluate pharmacokinetics (PK) and antitumor activity by RECIST v1.1 (part 1) and PK, safety, tolerability, and CNS antitumor activity (part 2). Dose escalation will utilize a 3+3 design with up to 6 patients per cohort in part 1. Part 2 will enroll patients in 5 cohorts (n = 10 or 29 each), including patients with NSCLC who have (1) new or progressing CNS metastases including leptomeningeal disease after treatment with osimertinib, (2) active CNS disease and ex20ins mutations, (3) ex20ins mutations without CNS disease and (4) other rare mutations, based on a Simon 2-stage design. First patient was treated in October 2022 and enrollment is ongoing. The study is planned for approximately 35 centers in North America and Asia-Pacific region. Clinical trial information: NCT05514496 .
Community outreach in vulnerable populations: Skin cancer screening for firefighters.
Authors: Christopher Fay, Shauna Rice, Steven Krueger, Jessica St John
Journal: Journal of Clinical Oncology (2023)

e21587 Background: Firefighters have both an increased risk (21%) and 20-year younger median age (42) at diagnosis of melanoma compared to the general population. The World Health Organization classifies firefighters’ occupational exposures as "carcinogenic to humans," but there is limited knowledge regarding sun protection habits, skin cancer history, and community outreach in this at-risk population. Methods: Free, full-body skin examinations conducted by board-certified dermatologists using the American Academy of Dermatology’s SPOT Skin CancerTM screening form were offered to firefighters from 26 cities and towns in Massachusetts on two separate days in August 2021 and October 2022. Data from the screening form and subsequent skin biopsy results were obtained and reported. Results: Of 195 firefighters screened, 30 (15.4%) were referred for biopsy. All were white males, mean age was 44.7 years, 26.7% had prior tanning bed exposure, 80% had prior blistering sunburns, 20% used sunscreen regularly, 86.7% did not have a regular dermatologist, and 6.7% had a history of keratinocyte-based skin cancer. Nineteen (63.3%) had biopsies, most frequently on the back or face, which resulted in three nodular basal cell carcinomas and 11 dysplastic nevi (seven moderate-to-severe). Conclusions: Firefighters are an underrecognized vulnerable population for the development of skin cancer. Community outreach in the form of free skin cancer screenings is a successful model for increasing awareness and early diagnosis of skin cancer among this population. In addition to providing access to care, community screenings offer tailored educational opportunities that promote skin cancer prevention in this high-risk group.
Tumor immune microenvironment in <i><i>BRAF </i></i>V600E mutant lung adenocarcinoma.
Authors: Yutao Liu, Mingzhao Wang, Tong Chen, Weihua Li, Xingsheng Hu, Jun Jiang, Fang Li, Zhiyi Wan, Jie Zhang, Chunmei Zhang
Journal: Journal of Clinical Oncology (2023)

e21003 Background: The efficacy of immune checkpoint inhibitors (ICIs) is closely related to tumor immune microenvironment (TIME). However, little is known about the role of BRAF V600E mutation in the TIME of lung adenocarcinoma (LUAD). Methods: Here, we analyzed the TIME of LUAD with the BRAF V600E mutation using RNA sequencing and multiplex immunofluorescent (MIF) stained with CD8, CD68, CD163, CD57, PD-1, and PD-L1 antibodies. Patients were divided into the BRAF V600E (n = 31) and driver gene ( ALK, BRAF, EGFR, HER2, KRAS, MET, RET, and ROS1) wild-type groups (WT, n = 32). Results: There were no significant differences between the BRAF V600E and driver gene WT groups in terms of immunological signature scores, including T cell–inflamed gene expression profiles, adhesion molecules, chemokines, cytolytic activity, immunocostimulators, immunoinhibitors, MHC Class I, MHC Class II, MHC Non-Class, IFNg signature, tertiary lymphoid structure, and most of infiltrating immune cell subtypes. MIF showed that the proportions of PD-L1+ cells and CD68-associated tumor-associated macrophages (TAMs) were significantly higher in the BRAF V600E group in the tumor, stroma, and total regions. Notably, the majority of CD68-associated macrophages were CD68+CD163- TAMs. However, the proportions of CD8+, CD8+PD-L1+, and CD8+PD-1+ tumor-infiltrating lymphocytes (Tils) in the BRAF V600E and driver gene WT groups were all comparable in the tumor, stroma, and total region. Conclusions: The TIME was generally similar between the BRAF V600E mutant and driver gene wild-type groups, particularly in the proportion of CD8+ Tils. This may support that BRAF V600E mutation does not affect the efficacy of immune checkpoint inhibitors in LUAD.
Impact of BAP1 mutational status on immunotherapy outcomes in advanced malignant pleural mesothelioma: A single institution experience.
Authors: Olisaemeka Ogbue, Serhan Unlu, Sharmeen Sorathia, Abdel Rahman Nanah, Fatima Abdeljaleel, Abdo S. Haddad, Hamed Daw
Journal: Journal of Clinical Oncology (2023)

e20537 Background: Malignant pleural mesothelioma (MPM) is a rare and aggressive tumor of mesothelial cells usually diagnosed at advanced stages with dismal prognosis. Most patients progress after 1 st line systemic chemotherapy. In the last decade, single or dual agent immune checkpoint inhibitor (ICI) therapy has emerged as a therapeutic option. BAP1 is a commonly mutated tumor suppressor gene in MPM that has been shown to correlate negatively with survival in other solid tumors. We sought to determine the impact of BAP1 mutation on outcomes with ICIs when used as second line systemic therapy. Methods: We retrospectively reviewed a cohort of MPM patients who received ICIs at the Cleveland Clinic foundation between 2017-2022. Patients must have progressed after 1 st line systemic chemotherapy prior to ICI. We then compared oncologic outcomes of ICI therapy based on BAP1 mutational status on Next-Generation Sequencing (NGS). End points of interest were overall response rate (ORR) and progression free survival (PFS) while on ICIs. Results: There were a total of 43 MPM patients who received ICIs following progression on pemetrexed/carboplatin (Median age 74 years, IQR 66-81, range 57-92) with a male predominance (M:F ratio 39:4). Histologies included- 58% epithelioid, 28% sarcomatoid and 14% mixed/biphasic histology. Single agent ICI therapy with nivolumab or pembrolizumab was used in 65%. Median follow up was 3 months. BAP1 mutation on NGS was detected in 16%. Other mutated genes included CDKN2A- 7%, BRAF- 5%, MTAP 2% and PTEN 2%. We compared baseline characteristics and outcomes between BAP1 wild type (WT) and BAP1 mutated (MT) groups. Median age at mesothelioma diagnosis were similar 74 vs 70 years (0.3347) with no significant differences in either asbestos or smoking exposure (Table 1). An analysis of outcomes revealed an ORR to ICI of 33% (36% vs 29% respectively [p = 0.9]). PFS was similar between both groups - 4 months [95% CI, 3-NA] for BAP1 WT vs 4 months [95% CI, 2-18] for BAP1 MT group. Conclusions: BAP1 mutation had no prognostic significance on either response rates or disease progression while on ICI therapy in our cohort of advanced MPM patients. The identification of predictive biomarkers for immunotherapy of MPM is an area of unmet clinical need. [Table: see text]
Factors affecting administration of palliative care in primary central nervous system tumors: An NCDB analysis.
Authors: Daniel Spalinski, Daniel Nguyen, Michael Hoenack, Ali Memon, Sherif Zineldine, Peter T. Silberstein
Journal: Journal of Clinical Oncology (2023)

e24146 Background: Primary central nervous system (CNS) tumors are a diverse group of neoplasms that can vary greatly in terms of their cellular origin, histological features, clinical behavior, and prognosis. Many diagnoses leave patients with a poor prognosis and an impaired quality of life. Palliative care (PC) has long been used as a means to improve quality of life and symptoms associated with debilitating malignancies; however, its use in CNS tumors is not well characterized. Yet, the plethora of life-altering symptoms such as gait impairment, cognitive decline, motor deficits, and seizures provide a need for further multidisciplinary approaches to integrating PC with primary CNS tumor diagnoses. We aim to assess factors that influence the receipt of PC in the current data on central nervous system tumor patients and assess differences in overall survival. Methods: This study retrospectively evaluated the use of PC in patients with single primary malignant central nervous system tumors (gliomas, neuroepitheliomatous neoplasms, and meningiomas) diagnosed and recorded in the National Cancer Database (NCDB) between 2004 and 2020. Patients were identified by ICD-O-3 coding and patients with other malignancies were excluded. Multivariable logistic regression was performed to evaluate associations between patient characteristics and the use of PC, and Kaplan-Meier curves with log-rank analysis were used to determine survival for each group. Results: After excluding patients without information on utilization of PC, a total of 9295 patients with primary CNS tumors were considered in the final analysis. Overall, 1.31% received palliative care. From patients receiving palliative care, 81.1-93.4% received non-curative treatment with surgery, radiation, chemotherapy, or a combination of one or more of these modalities with additional pain management. Odds of receiving palliative care were decreased in black patients, patients who received non-palliative surgical treatment, patients with a primary tumor site at the optic chiasm, patients with unilateral tumors, and patients with private, medicaid, other government, or unknown insurance status. Odds of receiving palliative care were increased with increased Charlson-Deyo Score, in patients receiving non-palliative systemic or radiation treatment, and patients with a primary site at the spinal dura. Utilization of PC was associated with a decreased 1-year and 5-year overall survival. Conclusions: PC use in CNS tumors was influenced by tumor location, treatment type, insurance status, patient race, and comorbidity index. This study demonstrates the areas in which use of PC utilization is still lacking across a diverse set of CNS tumors and patients. Further exploration is needed into the integration of palliative care broadly across these malignancies as it still remains low despite the abundance of quality-of-life altering symptoms.
Sequential intravenous chemotherapy with drug-eluting bead bronchial arterial chemoembolization for the treatment of stages III and IV lung squamous cell carcinoma: A retrospective controlled clinical study.
Authors: Jianfei Tu, Lingqiang Lai, Dengke Zhang, Xihui Ying, Li Chen, Jiahao Wu, Jie Chen
Journal: Journal of Clinical Oncology (2023)

8548 Background: To determine the differences in efficacy and safety between drug-eluting bead bronchial arterial chemoembolization (DEB-BACE) combined with intravenous chemotherapy and systemic chemotherapy alone for the treatment of stages III and IV lung squamous cell carcinoma (LSCC). Methods: 136 patients with stages III and IV LSCC were retrospectively recruited between January 2018 and August 2021 and divided into group A (chemotherapy-only, N = 95) and group B (DEB-BACE combined with intravenous chemotherapy, N = 41). The short-term efficacy, hemoptysis and dyspnea remission rates, and incidence of adverse reactions were compared between the two groups. Survival estimation was performed by Kaplan-Meier, and the Log-rank test was performed to compare survival differences between groups. Results: The One-month DCR (90.2% vs. 49.5%) and ORR (75.6% vs. 38.9%) were better in group B than in group A (both P &lt; 0.05). Progression-free survival (PFS) was 8.0 months in Group B and 6.0 months in Group A, a statistically significant difference (P &lt; 0.05). The PFS rates at 6, 12, and 24 months were 63.4%, 24.4%, 0.0%, 43.2%, 13.7%, and 0.0% in groups B and A, respectively, this difference was significant (P &lt; 0.05). The median overall survival was better in group B than in group A (19.0 vs 14.0 months, P &lt; 0.05). The OS rates at 6, 12, and 24 months were 100%, 85.4%, 26.8%, 78.9%, 56.8%, and 22.1% in groups B and A, respectively, with statistically significant differences (P &lt; 0.05). The hemoptysis and dyspnea remission rates were better in group B than in group A within one month after treatment (P &lt; 0.05), however, in terms of the incidence of adverse reactions, incidences, such as post-treatment fatigue and bone marrow suppression, were significantly lower in Group B than in Group A during the follow-up period (P &lt; 0.05). Conclusions: DEB-BACE combined with intravenous chemotherapy is effective for the treatment of advanced LSCC, with lower adverse reactions, and significant improvement in patients' hemoptysis and dyspnea symptoms, which is worthy of clinical application.